Compass Health SOP: Purchasing Overview
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Questions and Answers

What is the primary requirement for purchasing Class-II or Critical products/services?

  • Purchases can only be made for custom requirements.
  • Specifications must be communicated to the supplier prior to purchase. (correct)
  • Purchase can be made without supplier communication.
  • Verification is not necessary for these products.

What does the QA department periodically monitor in relation to purchasing activities?

  • Supplier compliance with non-critical product requirements.
  • General supplier performance metrics unrelated to purchasing.
  • Sales forecasts for future purchasing needs.
  • Purchasing activities to ensure adherence to the process. (correct)

How should the results of purchasing activity monitoring be handled?

  • Results should be made available to management at each Management Quality Review. (correct)
  • They should be disclosed only to the suppliers involved.
  • They are kept confidential and not shared with management.
  • They should be reported once a year regardless of findings.

What does the Purchase Order Form capture?

<p>Specifications and nature of the product ordered. (A)</p> Signup and view all the answers

What is required for purchases made off the shelf without prior specifications?

<p>Only information about quantities is necessary. (A)</p> Signup and view all the answers

Who is responsible for compiling purchase requirements with input from other personnel?

<p>Originator (A)</p> Signup and view all the answers

What is the primary role of QA-RA in the purchasing process?

<p>To monitor purchasing activities periodically (C)</p> Signup and view all the answers

What must be documented when a need for a product is identified?

<p>Nature of the product (C)</p> Signup and view all the answers

Which of the following should be included in product specifications?

<p>Design parameters and performance description (C)</p> Signup and view all the answers

What is required from suppliers regarding changes to the purchased product?

<p>Notification of changes prior to implementation (B)</p> Signup and view all the answers

Before communicating purchase specifications to suppliers, what must be ensured?

<p>Specifications are adequate and reviewed (A)</p> Signup and view all the answers

What aspect of the purchasing process is the Management responsible for reviewing?

<p>Documentation adequacy and sufficiency (C)</p> Signup and view all the answers

What may be required if sampling is performed by the supplier?

<p>A sampling plan (C)</p> Signup and view all the answers

What is the primary purpose of the purchasing procedure?

<p>To maintain the quality, safety, and effectiveness of products and services. (D)</p> Signup and view all the answers

Which of the following items is NOT covered by the purchasing procedure?

<p>Standard office supplies. (B)</p> Signup and view all the answers

Which regulatory standard specifically addresses purchasing controls?

<p>FDA QSR § 820.50 (C)</p> Signup and view all the answers

What does the acronym SOP stand for?

<p>Standard Operating Procedure (C)</p> Signup and view all the answers

Which document would be used to evaluate potential suppliers?

<p>Supplier Evaluation Form (D)</p> Signup and view all the answers

What form is used to document the details of the product being purchased?

<p>Purchase Order Form (QMS-FRM-0067) (C)</p> Signup and view all the answers

What classification is assigned to products/services with a low risk of affecting quality?

<p>Class I (A)</p> Signup and view all the answers

What should be done when a service requirement is communicated to a supplier?

<p>It must be discussed to ensure understanding. (C)</p> Signup and view all the answers

Which document is used to log all purchases made?

<p>Purchasing and Receiving Log (QMS-REC-0066) (C)</p> Signup and view all the answers

What is the role of QA-RA in the classification of products and services?

<p>To determine classification along with necessary stakeholders. (C)</p> Signup and view all the answers

What happens if critical products or services fail to meet specified requirements?

<p>It could cause significant degradation in product performance. (B)</p> Signup and view all the answers

Flashcards

Purchasing SOP

A standard operating procedure for acquiring products, materials, and services. It ensures the quality, safety, and effectiveness of Compass Health Inc.'s products and services.

Scope of Purchasing SOP

Applies to products and services affecting Compass Health's quality, safety, and effectiveness. Does not include standard items like office supplies or airfare.

Applicable Standards

FDA QSR § 820.50 Purchasing Controls, ISO 13485:2016 Section 7.4.Purchasing, and TG(MD)R Sch1 P1 2, Sch3 P1 Cl1.4(5)(d)(ii).

Supplier Evaluation Form

A form used to assess potential suppliers and their suitability.

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Purchase Order (PO)

A document authorizing the purchase of goods or services.

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Purchasing and Receiving Log

A record of purchases and receipts kept by Compass Health.

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Approved Suppliers List

A list of suppliers that have met Compass Health's standards and are accepted for business.

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Standard Operating Procedure (SOP)

A set of step-by-step instructions for completing a specific task or process.

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Purchasing Process Originator

The person who identifies a need for a product and initiates the purchase request.

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Purchase Requirements

Detailed specifications for a product, including quantity, materials, performance, and any required approvals or certifications

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Supplier Evaluation

Compass Health evaluates suppliers to ensure they meet quality requirements.

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Product Specifications

Detailed descriptions of required product characteristics, including design parameters, quantity, and quality standards.

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Purchase Requisition Review

Checking the validity and completeness of the product specifications before sending them to suppliers.

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Supplier Qualification

Verification of supplier's ability to meet the required product specifications and quality standards.

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Product Changes Notification

Suppliers must inform Compass of any changes to the product before implementing them.

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Quality Assurance (QA-RA)

QA-RA monitors the purchasing process to ensure adherence to the established procedures.

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Purchase Order Form

A document used to officially order goods or services from a supplier.

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Expense Policy

Compass Health's guidelines for employees' use of personal credit cards for business expenses.

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Service Requirement Communication

The process of ensuring suppliers fully understand Compass's needs and expectations for a service.

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Training for Suppliers

Providing training to suppliers on internal processes or external regulations.

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Product/Service Classification

Categorizing products and services based on their risk level of impacting Compass Health’s quality.

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Critical Products/Services

Products or services that have a high risk of affecting Compass Health’s products or services, and their failure could significantly impact performance.

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Class-II or Critical Products

Products or services that require specific requirements and specifications to be communicated to the supplier before purchase.

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Off-the-Shelf Purchases

Products or services purchased without providing specific requirements or specifications beyond basic quantities or similar information.

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Verification of Purchased Product

Verifying purchased products against specified requirements and specifications.

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Study Notes

Compass Health SOP: Purchasing

  • Purpose: Establishes controls for acquiring products, materials, and services to maintain quality, safety, and effectiveness. Ensures purchased items meet specifications.

  • Scope: Applies to products and services impacting Compass's overall quality, safety and effectiveness. Excludes standard/commodity items (office supplies, furniture, airfare, etc).

  • Applicable Standards/Regulations:

    • FDA QSR § 820.50 Purchasing Controls
    • ISO 13485:2016 Section 7.4 Purchasing
    • TG(MD)R Sch1 P12, Sch3 P1 Cl1.4(5)(d)(ii)

  • Reference Documents:

    • Supplier Evaluation Form (QMS-FRM-0060)

Purchasing and Receiving Log

  • Related Documents:
    • Purchase Order Form (QMS-FRM-0067)
    • Approved Suppliers List (QMS-REC-0045)
    • SOP: Document Controls (QMS-SOP-0002)
    • SOP: Control of Records (QMS-SOP-0003)
    • SOP: Software Development Process (QMS-SOP-0008)
    • SOP: Risk Management (QMS-SOP-0013)

Process Roles

  • Originator: Initiates the purchase requests and compiles requirements with appropriate personnel

  • QA/RA: Spot-checks & monitors purchasing activities to ensure compliance.

  • Management: Reviews documentation, expenditure appropriateness and supplier selection.

Purchasing Process

  • The process is outlined in Figure 1 (not included, but referenced in text).
  • Compass evaluates suppliers, purchasing only from those meeting quality requirements (SOP: Supplier Evaluation and Monitoring).

Purchasing Information

  • Potential suppliers are identified and evaluated according to SOP (Supplier Evaluation and Monitoring) and documentation is captured on a Purchase Order Form (QMS-FRM-0067)
  • Supplier evaluations follow outlined criteria/procedures.

Conducting a Purchase

  • Products: Purchased using a Purchase Order Form (QMS-FRM-0067) or company credit card, as appropriate. Purchases are logged in the Purchasing and Receiving Log (QMS-REC-0066) using a unique PO number. Personal credit card purchases are expensed via company policy.

  • Services: No specified limits; service requirements communicated/discussed with supplier, documented, and trained where necessary

Classification of Products/Services

  • Products/services are categorized as Class I (low/no risk), Class II (medium risk), or Critical (high risk) based on potential impact on Compass products.

  • Critical/Class II products/services need specifications communicated before purchasing.

  • Off-the-shelf Critical/Class II purchases don't require prior communication if specifications are already clear, and quantities are defined.

Verification of Purchased Product

  • Verification is conducted according to a specific SOP.

Process Monitoring

  • QA periodically monitors purchasing activities to ensure compliance in adherence to the SOP's requirements. Non-compliance will be addressed.

Quality Records

  • Purchase Order Form: Used to formally order materials/components from suppliers.
  • Purchase & Receiving Log: Lists all purchase and receiving requests from personnel.
  • Purchase Order Records: Completed Purchase Order forms.

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Related Documents

Compass Health AI Purchasing SOP PDF

Description

This quiz covers the Standard Operating Procedures (SOP) for purchasing at Compass Health. It focuses on the controls for acquiring products and services that ensure quality, safety, and effectiveness. Key regulations and related documents will also be discussed.

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